Synthes (USA) Products LLC recalls PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Us…

Recall date

January 31, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1383-2017

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

US distribution to TX and LA

Why it was recalled

These items are incorrectly etched and labeled. The item etched and labeled as 10mm Strut 03.820.350 lot 5919005 is a 12 mm Strut. The item etched and labeled as 12 mm Strut 03.820.352 lot 5919006 is a 10 mm Strut.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment open and facilitate discectomy